Virtual Patient Behavioral Response Training for Family Caregivers

Alzheimer Disease Clinical Trial

Official title:

Virtual Patient Behavioral Response Training for Family Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04489303
• Other study ID #: Pz-A107a
• Status: Completed
• Phase: Phase 2
• Start date: May 15, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: May 2023
• Source: Photozig, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Our study is designed to help caregivers of someone with Alzheimer's Disease and related dementia to understand and deal with the difficult behaviors of a person with dementia.

Description:

The goal of this study is to develop and evaluate the Caring Response mobile app, containing a training that builds skills and stimulates practice. The investigators are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. The research team is designing the program to help to enhance caregivers' skills to deal with difficult behaviors, reduce distress, and improve quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Care for an individual with Alzheimer's Disease or other dementia.

• Own a smartphone or tablet and have Internet access.

• Minimum age of 18 years old.

• Spend at least 8 hours/week caring for a person with dementia.

Exclusion Criteria:

• Severe psychological or physical illness.

• Inability to read and follow English instructions.

• High level of depressive symptoms.

• Unwillingness to participate in all aspects of the study.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Behavioral:
• Caring Response App
Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.
• Traditional Educational/Resources Program
Participants will receive a traditional educational/resources program, containing a workbook and online resources.

Locations

Country	Name	City	State
United States	Photozig, Inc.	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Photozig, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revised Memory and Behavior Problems Checklist	This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome.	3 months
Primary	Center for Epidemiological Studies Depression Scale	The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome.	3 months
Primary	Perceived Stress Scale	The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.	3 months